Surgical orthopedic bone staples are used in repairing fractured bone and/or bone that has undergone a surgical procedure for therapeutic purposes, e.g., deformity correction, reconstruction, arthrodesis, etc. Additionally, bone staples may be used to attached soft tissue, e.g., ligaments or tendons, to bone and may be used in conjunction with one or more fasteners, e.g., a bone plate and/or bone screws. Bone staples may be used to fuse bone in various anatomic locations of the human body such as bones of the foot, ankle, hand, and wrist, though the application is not limited to these areas. Their application is such that each leg of the staple is placed on an opposite side of the bone interface. In this light, the bone staples provide compression at the bone interface to promote fusion and allow surgeons to maintain bones in a desired anatomic position while attaching additional fixation means such as a bone plate or bone screws. Bone staples also may be utilized independently to fix or stabilize bones, or attach tissue to bone, and provide a low profile after implantation that is preferred where soft tissue coverage is limited such as in the extremities, for example the foot and hand.
Bone staples also provide a relatively simple and quick means of bone fixation and stabilization because of their relative ease of placement and thus removal after fusion takes place. Many bone staples are made of Nitinol and take advantage of the superelastic property of this material. The implant is formed with the legs in a compressed or inwardly biased state, which is expanded prior to implantation so that there is material bias to return to the compressed state to impart compression at the bone interface when implanted. Nitinol staples are designed and manufactured with specific dimensions and parameters, respectively, to provide specific compression forces. It is, therefore, desirable that the staples are delivered to the surgeon in a state that facilitates surgical application as well as optimal performance after implantation.
Traditionally, bone staples come in one of two forms. The first type are provided by the manufacturer in a non-sterilized form, which must be sterilized prior to use and then mounted to an insertion tool, which must also be sterilized, requiring multiple additional steps to be performed by the surgery team prior to use. The second type is generally provided by the manufacturer in a pre-sterilized form already mounted to a rigid insertion device and packaged in sterile packaging. However, such staples are pre-mounted in their expanded format or configuration. Where staples are supplied in the expanded format or configuration after days, weeks, or months of shipping, warehousing, and packaging in varying temperatures and conditions, the staple may be damaged or its elasticity may be reduced such that the staples is unable to return to its biased configuration to apply compression forces on the bone fragments or sections. Such tools, due to their fixed nature, also place additional forces on the staple and patient's bone when they are removed, thereby causing the possibility of transferring unwanted forces into a patient's newly repaired bones. Therefore, it would be advantageous to provide a pre-sterilized staple and insertion tool that can be delivered to surgeons in a non-expanded format. The preferred present invention addresses the above-described shortcomings of the prior art bone staples.